The FDA approved the first generic version of the Proventil HFA (albuterol sulfate) metered-dose inhaler for treating bronchospasm.
The FDA indicated the generic inhaler from Cipla for the treatment or prevention of bronchospasm in patients four years of age or older with reversible obstructive airway disease. It also aids in the prevention of exercise-induced bronchospasm in the same age group.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” FDA commissioner Dr. Stephen Hahn said in a news release. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
In March, the FDA issued a revised draft product-specific guidance for proposed inhalers of this kind, including products referencing Proventil HFA. Individual companies can meet with the FDA as part of its pre-abbreviated new drug application program in support of the development of generic drug products.
The administration listed upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate, tremor and nervousness as side effects commonly associated with the albuterol sulfate metered-dose inhaler, 90 mcg/inhalation.
